Genetesis Accelerated Registry
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Accuracy of Cardioflux diagnosis/screening of ACS
研究概览
简要总结
Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The purpose of the Genetesis Accelerated Registry (GEAR) study is to understand the potential for magnetocardiography to be utilized as a diagnostic, screening or surveillance tool for heart disease in healthy and non-healthy volunteers. Magnetocardiography (MCG) is a diagnostic method that analyzes and records the magnetic fields of the heart for the detection of various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 500 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age at the time of enrollment.
排除标准
- •< 18 years of age
- •Patients unable to fit into device
- •Non-ambulatory patients
- •Patients with present with or have reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium
- •Patients with claustrophobia or unable to lie supine for 5 minutes
- •Pregnant women
- •Poor candidate for follow-up (e.g. no access to phone)
- •Patients with a language barrier/language difficulties
结局指标
主要结局
Accuracy of Cardioflux diagnosis/screening of ACS
时间窗: 12 months
Comparing the accuracy of Cardioflux to current standard of care when diagnosing/screening for ACS
次要结局
未报告次要终点
